In-home first-dose observation contraindications | |
Factors that contraindicate in-home fingolimod initiation, owing to the need for overnight electrocardiogram monitoring in a medical facility | Patients who poorly tolerate bradycardia or may experience serious heart rhythm disturbances, including those with: |
ischemic heart disease | |
history of myocardial infarction | |
congestive heart failure | |
history of cardiac arrest | |
cerebrovascular disease | |
uncontrolled hypertension | |
history of symptomatic bradycardia | |
history of recurrent syncope | |
severe untreated sleep apnea | |
atrioventricular block | |
sinoatrial heart block | |
General contraindications | |
Factors that contraindicate treatment with fingolimod | Patients who in the preceding 6 months have experienced: |
myocardial infarction | |
unstable angina | |
stroke | |
transient ischemic attack | |
decompensated heart failure requiring hospitalization | |
Class III/IV heart failure | |
Patients with a history or presence of: | |
Mobitz type II second- or third-degree atrioventricular block | |
sick sinus syndrome (unless the patient has a pacemaker) | |
a baseline corrected QT interval ≥ 500 ms | |
Patients with cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or class III anti-arrhythmic drugs (see Table 2) | |
Patients who have experienced a hypersensitivity reaction to fingolimod (or its excipients) including rash, urticaria, or angioedema |